A clinical trial to compare subcutaneous injection versus intravenous injection of tramadol for extremities injuries with moderate pain in the emergency department

Not Applicable

Completed

Conditions: Pain associated with extremities injuries
Nervous System Diseases
Pain

Registration Number: ISRCTN15316150

Lead Sponsor: niversity of Malaya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 198

Inclusion Criteria

1. Patients voluntarily sign the informed consent form
2. Patients presenting with extremities injuries - defined as injuries to the upper limbs including the shoulders, and injuries to the lower limbs excluding the hip
3. Soft tissue injuries or suspected soft tissue injuries (skin abrasions, sprains, strains, ligament injuries, muscle injuries)
4. Closed fracture or suspected closed fracture
5. Moderate pain (pain score of 4, 5 or 6 using verbal numerical rating scale)

Exclusion Criteria

1. Patients with open fractures as they will require procedural sedation for early reduction
2. Patients with laceration wounds as they will require local anaesthesia for wound suturing
3. Patients who will require admission
4. History of allergy or suspected allergy to tramadol
5. Pregnant patients
6. Patients with known liver disease
7. Patients who had consumed or had received any analgesia prior to presentation to the emergency department
8. Patients who are taking analgesia for other pathology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain score, as measured using verbal numerical rating scale, at 30 min after the administration of tramadol

Secondary Outcome Measures

Name	Time	Method
1. Time from administration of tramadol to pain relief (or to decision to administer rescue analgesia) <br>2. Pain score associated with subcutaneous injection and intravenous cannulation<br>3. Incidence of any local or systemic side effects<br>4. Need for rescue analgesia<br>5. Need for anti-emetic<br>6. Patient's overall satisfaction using a 5-point Likert scale